NCT04936321Completed
Intervention for Sleep and Pain in Youth: A Randomized Controlled Trial
Enhancing the Efficacy of Migraine Self-Management in Children With Comorbid Insomnia
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
Insomnia is a common comorbidity among adolescents with migraine. This randomized controlled clinical trial aims to determine efficacy of cognitive-behavioral therapy (CBT) for insomnia, as well as the combined effect of CBT insomnia and pain interventions, on reducing insomnia symptoms and headache-related disability in adolescents with migraine. The long-term goal is to offer effective, tailored self-management interventions that can address migraine and co-morbid sleep problems in adolescence and disrupt a cycle of persistent, disabling migraine from continuing into adulthood.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 224 (actual)
- First submitted
- 8 Jun 2021
- Start date
- 1 Oct 2021
- Primary completion date
- 12 Mar 2026
- Lead sponsor
- Seattle Children's Hospital
- Diseases
- Migraine
- NCT number
- NCT04936321
What you commit to
- Study type: Interventional
- Participants enrolled: 224
- From 1 Oct 2021 to the primary completion date, 12 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosed sleep disorder (e.g. sleep apnea, narcolepsy)
- A serious comorbid chronic condition (e.g., diabetes, arthritis, cancer)
Other
- Non-English speaking
- Unable to read at 5th grade level or complete surveys independently
Who the study is looking for
- 11-17 years old
- Headache present for at least three months and insomnia symptoms for the past month
- Access to the Internet on any web-enabled device
Age in the registry: 11 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.